FDA applicant
Endotronics, Inc.
FDA records 3 decisions for Endotronics, Inc. (Coon Rapids, MN) from 1986 to 1988: 3 510(k) clearances. All are in product code KJH (Apparatus, Perfusion). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Endotronics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Endotronics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Endotronics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report